A Culture of Quality
Recently in reviewing the newly released FDA compliance program manual based on the Quality Management System Regulation (QMSR), it states that a culture of quality is the product of specific behaviors, attitudes, activities, and processes sustained across the organization. As a quality practitioner, fostering a culture of quality within an organization is foundational, but I was curious to learn more about how FDA inspections will incorporate this moving forward. There is a footnote in the manual that refers to preamble comment number 27 regarding a culture of quality. The preamble notes that quality can’t be inspected into a product or service, it is achieved though product or service design. The FDA also emphasizes here the importance of maintaining control of the manufacturing of product or performance of the service.
A culture of quality within an organization needs to be supported from the top down. Senior management has the greatest influence over the organizational culture and how it is shaped. Ultimately management’s commitment is reflected in expenditure of resources; what positions are created or filled within an organization, amount of budgeted training hours, what performance metrics are tracked and acted upon, and how incidents and near misses are treated. These decisions shape the day-to-day behavior and long-term attitudes toward quality.
The FDA will assess these cultural elements indirectly through its inspections by examining the objective evidence: leadership engagement in quality management reviews and follow up which are now in scope of FDA inspections, allocation of resources, training records, corrective and preventive action (CAPA) effectiveness, and how quality reviews drive continual improvement. Inspectors will also evaluate behavioral indicators such as staff empowerment to raise concerns, responsiveness to nonconformances, and whether process changes are implemented and sustained using interviews, meeting minutes, observed practices, and trend data. Deficiencies in these areas could signal potential compliance concerns.
A true culture of quality is not a short-term initiative or the latest management fad; it is the product of sustained leadership commitment, consistent systems and practices, and ongoing investment in people and processes. This principle is especially relevant in light of the FDA release of the QMSR: organizations must align their quality systems and behaviors with these regulatory expectations to demonstrate effective, ongoing compliance. Organizations that embed quality into their values, decision-making, and day-to-day operations create durable improvements in compliance, product performance, and customer trust. Achieving a culture of quality requires patience, measurable goals and continuous learning so quality becomes the organization’s standard operating rhythm rather than a one-time campaign.
